Recall Z-2762-2019— Zimmer GmbH
Class II · Terminated
Class II FDA medical device recall by Zimmer GmbH, initiated 2019-08-21, terminated 2020-07-20. It names one FDA 510(k) clearance: K171858. Product: Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.. Reason: Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14..
- Recalling firm
- Zimmer GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-21
- Terminated
- 2020-07-20
- Firm location
- Winterthur, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
Reason for recall
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Data sourced from openFDA. This site is unofficial and independent of the FDA.